Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling - Final Rule

ICR 201412-0910-008

OMB: 0910-0624

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-12-09
ICR Details
0910-0624 201412-0910-008
Historical Active 200806-0910-002
HHS/FDA CDER
Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling - Final Rule
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 02/06/2015
Retrieve Notice of Action (NOA) 12/11/2014
  Inventory as of this Action Requested Previously Approved
02/28/2018 36 Months From Approved
19,480 0 0
1,590,400 0 0
0 0 0

The final rule requires the removal of the pregnancy categories A, B, C, D, and X from all human prescription drug and biological product labeling, and requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation. The final rule eliminates the "Labor and delivery" subsection because information about labor and delivery is included in the "Pregnancy" subsection. The final rule requires that the labeling include relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential.

US Code: 42 USC 262 Name of Law: Public Health Service Act
  
US Code: 21 USC 321(n) Name of Law: FD&C Act
US Code: 21 USC 371(a) Name of Law: FD&C Act
US Code: 21 USC 502(f) Name of Law: FD&C Act
US Code: 42 USC 262 Name of Law: PHS Act

0910-AF11 Final or interim final rulemaking 79 FR 72064 12/04/2014

No

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 19,480 0 8,232 11,248 0 0
Annual Time Burden (Hours) 1,590,400 0 422,495 1,167,905 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
Yes
Changing Regulations
This is a new data collection.

$500,000
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [email protected]

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
12/11/2014


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